Mass balance in HPLC Validation

GOOD VALIDATION PRACTICE (cGVP) LABORATORY, METHOD AND ANALYTICAL VALIDATION
1

How to establish mass balance in HPLC Method validations.I want clear explanation with examples.Can any body reply for
this question.
Thank you sir

2

Hi,

Please let me know in which aspect of HPLC you need the mass balance. Example : Column Resolution Verification or HPLC Product recovery Study ?

3

Dear sir how to establish mass balance for forced degrdation studies in HPLC method validation.I want clear explanation with examples.
Thank u

4

Mass balance can be established during impurity profiling , particularly when you go with LC-MS. [By Multi Ion Monitoring mode] or when you go with GPC. But this approach wil overkill the scope of validation, since the purpose of Forced Degradation is to know the Analytical capability, Degradation pathways & estimang instrinsic stability of molecule. Also, from our experience, FDA requires atleast 20-30 % degradation of the main component, not the mass balance. Mass balance shall be additional information during stability monitoring.

5

Dear all,

From Forced degradation study, mass balance will be estblished by using data of stressed and non stressed samples.
so kindly advice me, is there any limit for massbalance.

Thanks and Regards,
abhaskar

6

There is not requirement to achieve mass balance in every case. but in FD Study calculate sum of assay content of degraded sample and Degradation product and is nearly to Initial assay content.

7

sum up the impurities and assay value of the degraded sample , it can be equal to the sum of assay and impurites at the initial sample(before degradation).

Its not a official requirement for stability indicating assay methods.

Regards,
Bujji Reddy K
+91-9676749937

8

Hi,

Mass balance correlates the measured loss of a parent drug to the measured increase in the amount of degradation products. It is a good quality control check on analytical methods to show that all degradation products are adequately detected and do not interfere with quantitation of the parent drug (i.e., stability-indicating methods).

Read the full article with the following link

http://stabilitystudies.blogspot.in/2011/08/mass-balance-ratio.html